NCT06675357

Brief Summary

The goal of this clinical trial is to gain more information about how FAPI (fibroblast activation protein inhibitor) binds to certain type of cells in the tumor tissue. The main question it aims to answer is how this information can be used to better diagnose and track prostate cancer. Participants will undergo two PET/MRI scans during two research visits, each of which may last up to 2.5 hours.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
8mo left

Started Feb 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

November 4, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 27, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 4, 2026

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

November 4, 2024

Last Update Submit

March 2, 2026

Conditions

Prostate Cancer Metastatic DiseaseProstate Cancers

Outcome Measures

Primary Outcomes (3)

  • Performance of FAPI for lesion detection

    Sensitivity and specificity for lesion detection on FAPI will be compared with that of PSMA PET, using a composite reference standard (all available histology, follow up clinical/standard of care imaging, serum PSA).

    Duration of scan, up to 80 minutes

  • Lesion FAPI uptake on PET

    FAPI uptake as measured by SUV will be correlated against tissue FAP positivity on immunohistochemistry and FAP expression on qPCR, using linear regression.

    Duration of scan, up to 80 minutes

  • Total FAPI-positive tumor volume change

    The total FAPI-positive tumor volume between pre- and post-treatment exams will be measured and compared to PSMA-response, other standard-of-care imaging response, and overall survival when available, using odds ratios for treatment response and Kaplan-Meier curve for survival.

    Duration of scan, up to 80 minutes

Study Arms (1)

Fibroblast activation protein inhibitor (FAPI)

EXPERIMENTAL

FAPI radiotracer will be used during PET

Radiation: FAPIProcedure: Positron Emission Tomography (PET)Procedure: Magnetic Resonance Imaging

Interventions

FAPIRADIATION

5 +/- 2 mCi of Ga-FAPI-46

Fibroblast activation protein inhibitor (FAPI)
Positron Emission Tomography (PET)PROCEDURE

Undergo PET scan

Fibroblast activation protein inhibitor (FAPI)
Magnetic Resonance ImagingPROCEDURE

Undergo MRI scan

Fibroblast activation protein inhibitor (FAPI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Able and willing to provide informed consent
  • Known diagnosis of prostate cancer
  • Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET
  • Optional: Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases.
  • Willing and able to undergo PET/MRI as part of this research

You may not qualify if:

  • Unable or unwilling to provide informed consent
  • Contraindication(s) to or inability to undergo PET/MRI
  • Participants for whom PET/MRI will delay timely delivery of treatment
  • Participants requiring intravenous (IV) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
  • Have their own prescription for the medication
  • The informed consent process is conducted prior to the self-administration of this medication
  • Come to the research visit with a driver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Ali Pirasteh, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Studies

CONTACT

608-282-8349Radstudy@uwhealth.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 5, 2024

Study Start

February 27, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

March 4, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

De-identified data with GE Healthcare: images, diagnosis, image quality scores, quantitative PET/MR measurements, BMI, weight, height, age and gender. The Department of Radiology Medical Imaging Research Support (MIRS) Radius team will serve as an honest broker for the sharing of de-identified data.

Locations

US(1)